The BIG Score and In-Hospital Trauma Mortality

Completed

• Conditions: Multiple Trauma; Injury Traumatic
• Interventions: Other: BIG SCORE; Other: Glasgow coma scale; Other: Revised Trauma Score; Other: Injury Severity Score

• Registration Number: NCT06574464
• Lead Sponsor: Haseki Training and Research Hospital

Brief Summary

This study investigated the efficacy and reliability of the BIG score, calculated based on the base deficit (BD), International Normalized Ratio (INR), and Glasgow coma scale (GCS), in comparison with the GCS, Revised trauma score (RTS), and Injury Severity Score (ISS) for predicting in-hospital mortality in adults with multiple-trauma presenting to the emergency department (ED).

Detailed Description

This retrospective, observational, single-center study included 563 consecutive adults (≥ 18 years old) with multiple trauma who were admitted to our emergency department and hospitalized between January 2022 and December 2023. We assessed patient demographics (age and sex), vital signs on admission (systolic blood pressure \[SBP, mmHg\], heart rate \[HR, beats/min\], respiratory rate \[RR, breaths/min\], and peripheral oxygen saturation \[SpO2, %\]), complaints and symptoms on admission, anatomic region of injury, type of trauma (blunt or penetrating), mechanism of injury, BD measured in blood gases, INR, trauma scoring systems (e.g., GCS, RTS, ISS, and BIG score), and clinical outcomes (discharge, hospitalization, or death). The study cohort was divided into survivors and non-survivors. Survivors were defined as patients who were still alive after 28 days, while non-survivors had passed away within that time. The demographics, clinical characteristics, and trauma scoring systems were compared between survivors and non-survivors to determine the prognosis of patients with multiple trauma. Independent predictors of mortality were determined by multivariate logistic regression analysis of variables (demographic characteristics, clinical characteristics, and trauma scores) that differed significantly between survivors and non-survivors. Receiver operating characteristic (ROC) curve analysis was performed to establish cut-off values for the GCS, RTS, ISS, and BIG score, and then to assess the sensitivity and specificity of these scoring systems in terms of predicting in-hospital mortality.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-12-01
• Study Completion: 2024-01-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-25
• Study First Submitted QC: 2024-08-25
• Last Update Submitted: 2024-08-25
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 563

Inclusion Criteria

• This study included 563 consecutive adults (≥ 18 years old) with multiple trauma who were admitted to our Emergency Department and hospitalized between January 2022 and December 2023.

Exclusion Criteria

• Patients aged < 18 years and adults who were discharged from the Emergency Department
• Patients with non-traumatic injuries and those who presented to the Emergency Department for reasons other than trauma
• Patients with missing Base Deficit and International Normalized Ratio levels
• Patients who had been admitted to the hospital more than 24 hours after the trauma
• Patients with single trauma (e.g., isolated extremity trauma, isolated head injury, etc.)
• Patients with chronic conditions such as chronic renal failure or hepatic, hematological, or neurological diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Survivors	Revised Trauma Score	Survivors were defined as patients who were still alive after 28 days of admission to the emergency department.
Survivors	BIG SCORE	Survivors were defined as patients who were still alive after 28 days of admission to the emergency department.
Non-survivors	BIG SCORE	Non-survivors had passed away within 28 days of admission to the emergency department
Non-survivors	Glasgow coma scale	Non-survivors had passed away within 28 days of admission to the emergency department
Non-survivors	Injury Severity Score	Non-survivors had passed away within 28 days of admission to the emergency department
Survivors	Glasgow coma scale	Survivors were defined as patients who were still alive after 28 days of admission to the emergency department.
Non-survivors	Revised Trauma Score	Non-survivors had passed away within 28 days of admission to the emergency department
Survivors	Injury Severity Score	Survivors were defined as patients who were still alive after 28 days of admission to the emergency department.

Primary Outcome Measures

Name	Time	Method
Predictive ability of Glasgow coma scale for 28-day mortality	From admission to 28 days	The investigators assessed the predictive ability of Glasgow coma scale in determining 28-day mortality.
Predictive ability of Injury Severity Score for 28-day mortality	From admission to 28 days	The investigators assessed the predictive ability of Injury Severity Score in determining 28-day mortality.
Predictive ability of Revised Trauma Score for 28-day mortality	From admission to 28 days	The investigators assessed the predictive ability of Revised Trauma score in determining 28-day mortality.
Predictive ability of BIG score for 28-day mortality	From admission to 28 days	The investigators assessed the predictive ability of BIG score in determining 28-day mortality.

Trial Locations

Locations (1)

Haseki Training and Research Hospital; 🇹🇷 Istanbul, Fatih, Turkey